BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 22336724 · Received June 26, 2025

    Report

    Report Number
    2016493-2025-90521
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    June 9, 2025
    Report Date
    June 20, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    MEA
    UDI-DI
    10885403812002
    PMA / PMN Number
    K043299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. ROOT CAUSE: THE PROBABLE CAUSE OF THE REPORTED DEVICE HAD CALIBRATION REQUIRED ERROR EVEN THOUGH CALIBRATION WAS ALREADY COMPLETED WAS NOT IDENTIFIED DURING THE CUSTOMER CALL. THE TECH SUPPORT RECOMMENDED TO PERFORM CALIBRATION ON PCA, IMMEDIATELY FOLLOWED BY PREVENTIVE MAINTENANCE TASK. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PCA PUMP MODULE KEPT SAYING "CALIBRATION REQUIRED" EVEN THOUGH CALIBRATION WAS ALREADY COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491074 ALARIS SYSTEM PUMP, INFUSION MEA CAREFUSION SD 8120 10885403812002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown